| CTRI Number |
CTRI/2025/01/079050 [Registered on: 20/01/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Use of probiotics Lactobacillus reuteri DSM 17938 and Lactobacillus rhamnosus GG in the treatment and prevention of functional abdominal pain in children |
|
Scientific Title of Study
|
Efficacy of Lactobacillus reuteri DSM 17938 versus Lactobacillus rhamnosus GG in the management of functional abdominal pain - A Randomised Controlled Trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vinoth |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Department of Paediatrics,
Room no.3,
First floor,
Paediatrics Out-Patient Building,Vinayaka Missions Medical College and Hospital.
Keezhakasakudymedu,Kottucherry Post,Karaikal.609609
Karaikal
PONDICHERRY
609609
India |
| Phone |
9080220712 |
| Fax |
|
| Email |
rajkantmc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vinoth |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Department of Paediatrics, Room no.3, First floor, Paediatrics Out-Patient Building,Vinayaka Missions Medical College and Hospital.
Keezhakasakudymedu,Kottucherry post,Karaikal.609609
Karaikal
PONDICHERRY
609609
India |
| Phone |
9080220712 |
| Fax |
|
| Email |
rajkantmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vinoth |
| Designation |
Associate Professor |
| Affiliation |
Vinayaka Missions Medical College and Hospital |
| Address |
Department of Paediatrics, Room no.3, First floor, Paediatrics Out-Patient Building,Vinayaka Missions Medical College and Hospital.
Keezhakasakudymedu,Kottucherry post,Karaikal.609609
Karaikal
PONDICHERRY
609609
India |
| Phone |
9080220712 |
| Fax |
|
| Email |
rajkantmc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vinayaka Missions Research Foundation,
Deemed to be University,
NH47,Sankari Main Road,
Salem,
Tamil Nadu.
India.
636308. |
|
|
Primary Sponsor
|
| Name |
Vinayaka Missions Research Foundation |
| Address |
NH47,Sankari Main Road,Salem,Tamil Nadu .636308 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrVinoth |
Vinayaka missions medical college and Hospital |
Department of Paediatrics, Room no.3, First floor, Paediatrics Out-Patient Building,
Keezhakasakudymedu,Kottucherry Post,Karaikal.609609
Karaikal
PONDICHERRY |
9080220712
rajkantmc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Vinayaka Missions Research Foundation Vinayaka Missions Medical College Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K599||Functional intestinal disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lactobacillus reuteri DSM 17938 |
Children with functional abdominal pain are given daily a chewable tablet of Lactobacillus reuteri DSM 17938 for a period of two months. |
| Comparator Agent |
Lactobacillus rhamnosus GG |
Children with functional abdominal pain are given daily a sachet of Lactobacillus rhamnosus GG to be dissolved in water and taken orally for a period of two months |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Children with functional abdominal pain not otherwise specified as per ROME IV criteria of Functional GastroIntestinal Disorders (FGID). |
|
| ExclusionCriteria |
| Details |
1)Children with an organic cause of abdominal pain,2)Children with functional dyspepsia,irritable bowel syndrome and abdominal migraine,3)Children with functional constipation,4)Children who had been on antibiotics and probiotics in the preceding two months,5)Children with chronic diseases and abdominal surgeries. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Lactobacillus reuteri DSM 17938 and Lactobacillus rhamnosus GG in the reduction of pain intensity and pain frequency of functional abdominal pain . |
At the end of treatment period of two months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Lactobacillus reuteri DSM 17938 and Lactobacillus rhamnosus GG in the reduction of pain intensity and pain frequency of functional abdominal pain |
At the end of a follow up period of six months after the completion of two months treatment. |
|
|
Target Sample Size
|
Total Sample Size="94"
Sample Size from India="94"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
17/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [rajkantmc@gmail.com].
- For how long will this data be available start date provided 18-02-2027 and end date provided 18-02-2030?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
Brief Summary
Modification(s)
|
Functional Gastrointestinal Disorders (FGIDs) are common in school aged children.The brain-gut axis play a predominant role in the pathophysiology of FGIDs.Probiotics are now emerging to be useful in Functional abdominal pain.Since there is a lack of RCT s involving probiotics in functional abdominal pain in India, we devised a one to determine the efficacy of Lactobacillus reuteri DSM 17938 and Lactobacillus rhamnosus GG in the management of functional abdominal pain. Children in the age group of 5 - 12 years will be randomised into two groups with one receiving Lactobacillus reuteri DSM and the other Lactobacillus rhamnosus GG daily for a period of two months after getting consent and assent from parents and children respectively.Pain intensity will be determined by a validated Wong Baker Faces pain scale which will be taught to parents and children.Baseline pain intensity and pain frequency per month will be marked for each participant before the intervention.Each parent of the trial participant will be given a diary to note the pain intensity using the pain scale and pain frequency daily.The diary will be checked biweekly during the treatment period and monthly during the follow up period of six months.The compliance of probiotic intake will be ensured by the scrutiny of empty probiotic covers brought by the parents and children when they come for review and diary-check.Statistical analysis from the data will be done at the end of treatment period and at the end of follow up period to determine the efficacy of Lactobacillus reuteri DSM 17938 and Lactobacillus rhamnosus GG in the reduction of pain intensity and pain frequency. A Likert scale satisfaction survey will be acquired form the parents and children at the end of the follow period of intervention. |